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FDA 510(k)

PUMP MODULES PMO LO-110-PMD 10-210

K-Number: K822071 · 1982-08-24

ApplicantGambro, Inc.
Decision Date1982-08-24
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PUMP MODULES PMO LO-110-PMD 10-210 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K822071. The device is classified under product code DWB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUMP MODULES PMO LO-110-PMD 10-210?

PUMP MODULES PMO LO-110-PMD 10-210 is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Gambro, Inc.. The 510(k) number is K822071.

When did PUMP MODULES PMO LO-110-PMD 10-210 receive FDA 510(k) clearance?

PUMP MODULES PMO LO-110-PMD 10-210 received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822071.

Who is the listed applicant for PUMP MODULES PMO LO-110-PMD 10-210?

The FDA 510(k) record lists Gambro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMP MODULES PMO LO-110-PMD 10-210?

The FDA product code for PUMP MODULES PMO LO-110-PMD 10-210 is DWB.

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Other records listing Gambro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: DWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTTerumo Cardiovascular Systems CorporationK112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,Terumo Cardiovascular Systems Corp.K973237CSS-CARDIOPLEGIA SAFETY SYSTEMMedtronic Bio-Medicus, Inc.K972321S3 MAST PUMPStoeckert InstrumenteK971520S3 CYCLIC RPM CONTROLStoeckert Instrumente

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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